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510(k) K882917

HI-LO TABLE, MODEL 820-05 by Tri W-G, Inc. — Product Code JFB

K882917 is an FDA 510(k) premarket notification submitted by Tri W-G, Inc. for the device "HI-LO TABLE, MODEL 820-05". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880. Tri W-G, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1988
Date Received
July 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Physical Therapy, Multi Function
Device Class
Class II
Regulation Number
890.5880
Review Panel
PM
Submission Type

Other clearances by Tri W-G, Inc.

  • K960196 — TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777 (February 7, 1996)
  • K945163 — ECHOCARDIOGRAPHY (February 17, 1995)
  • K941720 — MODEL 747 AND 747-30 EXAM/TREATMENT TABLE (May 6, 1994)
  • K936303 — TREATMENT TABLE MODIFICATION (March 18, 1994)
  • K933119 — HI-LO TREATMENT TABLES (October 12, 1993)
  • K932746 — MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE (July 21, 1993)
  • K930802 — MODELS 642 & 643 TILT EXAM/TREATMENT TABLE (March 22, 1993)
  • K925594 — MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE (February 12, 1993)
  • K923325 — MODEL 600 MEDICAL TREATMENT TABLE (July 21, 1992)
  • K922980 — 745-M (MAGNUM) (July 13, 1992)

Other clearances for product code JFB

  • K250266 — Ceragem Automatic Thermal Massager (CGM MB-2401) (July 11, 2025)
  • K241193 — AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) (January 31, 2025)
  • K243644 — Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) (January 8, 2025)
  • K243355 — Ceragem Automatic Thermal Massager (CGM-MB-1902) (November 27, 2024)
  • K240168 — N7-S (September 12, 2024)
  • K220572 — Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 (June 17, 2022)
  • K202937 — Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 (March 18, 2021)
  • K202113 — Ceragem Automatic Thermal Massager, Model CGM-MB-1901 (March 2, 2021)
  • K153054 — N5-1 (February 5, 2016)
  • K140592 — CERAGEM AUTOMATIC THERMAL MASSAGER (December 17, 2014)

FDA data resources